Job Title: Quality Associate
Location: Princeton, New Jersey (On-site)
Job Summary: We are seeking an experienced professional to oversee GMP compliance activities related to outsourced clinical manufacturing, packaging, labeling, and testing. Our team is focused on safeguarding the quality of investigational and commercial products through rigorous record review, data analysis, and cross-functional collaboration.
Responsibilities: Ensure GMP compliance for outsourced clinical manufacturing, packaging, labeling, and testing activities. Perform QA review of manufacturing and packaging batch records for accuracy and alignment with established requirements, and escalate issues or trends as appropriate. Review and approve analytical test results, support batch disposition workflows, and complete quality event records in digital systems. Support quality metrics, management reviews, and process improvement initiati...